BEUDAMED
    FDA Enforcement Class II Terminated

    Safety Sideport Knife 1.0mm 45¿, REF 378210 Product Usage: Indicated to make stab incisions during ophthalmic surgery

    Recall: Z-2342-2018 · Reported July 11, 2018

    Enforcement

    Recall Number
    Z-2342-2018
    Event ID
    80311
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Beaver Visitec
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 11, 2018
    Initiation Date
    May 14, 2018
    Classification Date
    July 2, 2018
    Termination Date
    June 8, 2021
    Address
    500 Totten Pond Rd, 10 City Point, Waltham, MA, 02451-1916, United States

    Description

    Safety Sideport Knife 1.0mm 45¿, REF 378210 Product Usage: Indicated to make stab incisions during ophthalmic surgery

    Reason

    Blades are loose in handles and may fall out due to non cured epoxy

    Code Info

    Lot Numbers: 6002436 & 6002663

    Distribution

    US Nationwide in the states of CA, IA, CO, HI, IA, MD & TX

    Quantity

    1354 units